ANDA 203965

ORIENT PHARMA CO LTD

FDA Drug Application

Application #203965

Documents

• Letter: 2015-03-03

Application Sponsors

ANDA 203965

ORIENT PHARMA CO LTD

Marketing Status

• Prescription: 001
• Prescription: 002
• Prescription: 003

Application Products

001	TABLET;ORAL	25MG	0	MIGLITOL	MIGLITOL
002	TABLET;ORAL	50MG	0	MIGLITOL	MIGLITOL
003	TABLET;ORAL	100MG	0	MIGLITOL	MIGLITOL

FDA Submissions

UNKNOWN;

ORIG

1

AP

2015-02-24

Submissions Property Types

ORIG

1

Null

15

TE Codes

001	Prescription	AB
002	Prescription	AB
003	Prescription	AB

CDER Filings

ORIENT PHARMA CO LTD

cder:Array
(
    [0] => Array
        (
            [ApplNo] => 203965
            [companyName] => ORIENT PHARMA CO LTD
            [docInserts] => ["",""]
            [products] => [{"drugName":"MIGLITOL","activeIngredients":"MIGLITOL","strength":"25MG","dosageForm":"TABLET;ORAL","marketingStatus":"Prescription","te":"","rld":"No","rs":"No"},{"drugName":"MIGLITOL","activeIngredients":"MIGLITOL","strength":"50MG","dosageForm":"TABLET;ORAL","marketingStatus":"Prescription","te":"","rld":"No","rs":"No"},{"drugName":"MIGLITOL","activeIngredients":"MIGLITOL","strength":"100MG","dosageForm":"TABLET;ORAL","marketingStatus":"Prescription","te":"","rld":"No","rs":"No"}]
            [labels] => 
            [originalApprovals] => [{"actionDate":"02\/24\/2015","submission":"ORIG-1","actionType":"Approval","submissionClassification":"","reviewPriority":"","inserts":"[{\"name\":\"Letter (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/appletter\\\/2015\\\/203965Orig1s000ltr.pdf\"}]","notes":"> Label is not available on this site."}]
            [supplements] => 
            [actionDate] => 2015-02-24
        )

)